E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Valutation of expression of receptors SSTR2 and/or 5 in neoplastic patients |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | HLGT |
E.1.2 | Classification code | 10022893 |
E.1.2 | Term | Investigations, imaging and histopathology procedures NEC |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Goals of the study are: to obtain better sensitivity and accuracy in post-surgical staging, in evaluation of the entity of disease spread in non surgical patients, in defining the primitive site in patients with evidence of metastases or secretion syndrome, restaging in the suspicion of relapse or metastases for evaluation for therapy with 90Y o 177Lu DOTATOC or DOTATATE, if in presence of SSTR2 and/or 5 receptors and in absence of documented therapeutic alternatives. |
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E.2.2 | Secondary objectives of the trial |
1. detection of the primary lesion, if present
2. metastastatic lesions > 2 cms
3. in case of extreme metastatic spread (massive secondary infiltration that can interest just one organ, but with lesions that cannot be counted), the comparative evaluation will only be qualitative |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients in need of the diagnostic procedure described above will be appointed by the endocrinological, oncological, medical or other centres or wards, or other hospitals, with the clinical information necessary to evaluate its appropriateness; the final decision shall be taken by the Nuclear Physician after an accurate evaluation of each patients clinical situation. In respect to the actual laws, the patient will be properly informed on the procedure and objectives of the scan, and asked to give written consent.
§ Patients of both sexes aged > 18 (for patients younger a specific authorisation will be submitted to this Ethics Committee), with histologically documented primitive tumour presumably expressing SSTR2 and/or 5: the main clinical question will be research of metastatic lesions in presence of a rise of specific markers or of symptoms due to hormonal incretion in productive neoplasms; in cases of advanced or metastatic disease, 68Ga DOTATOC or 68GaDOTATATE PET scan may be used as a preliminary step for treatment with the analogues labelled with beta- emitters; not only neuroendocrine tumours, but also thyroid, breast pulmonary SCLC and brain neoplasms shall be considered, these forms being susceptible to the above mentioned treatment only if positive to the diagnostic scan.
§ Patients consent to take part in the study, with written consent
In case of female patients in fertile age, the procedure will be performed exclusively in presence of a negative pregnancy test. |
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E.4 | Principal exclusion criteria |
Pregnancy (breast feeding will be interrupted) |
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E.5 End points |
E.5.1 | Primary end point(s) |
Selection of patients to trial with 90Y-DOTATOC |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 0 |